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临床试验/NCT07163806
NCT07163806尚未招募不适用

Diagnostic Value of Volumetric Parameters of 18F-FDG PET/CT in Characterizing Thyroid Incidentalomas.

Fatma Abelzaher Mahmoud Ahmed0 个研究点目标入组 88 人开始时间: 2025年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
88
主要终点
Assess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT

研究概览

简要总结

To assess the clinical significance of FDG-avid thyroid incidentalomas detected on PET/CT and explore correlations between SUV max, ultrasound characteristics, and histopathology for suspicious lesion.

详细描述

Thyroid incidentalomas are unsuspected thyroid lesions discovered during imaging performed for unrelated medical reasons. With the expanding use of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for cancer staging and follow-up, the detection of incidental thyroid nodules particularly those showing focal FDG uptake-has significantly increased (Are C et al., 2007; Kim TY et al.,2005). Although the overall prevalence of thyroid incidentalomas detected on PET/CT is relatively low (reported between 1.1% and 4%), the risk of malignancy among FDG-avid nodules is high, ranging from 26.7% to 64.6%, which is considerably greater than in non-FDG-avid nodules (Shi H et al.,2018; Makis W & Ciarallo A, 2017;Choi JY et al., 2006).

Globally, thyroid cancer is one of the most common endocrine malignancies, with an increasing incidence rate over the past two decades (Sung H et al.,2021). In Egypt, recent data indicate that thyroid cancer accounts for approximately 2.6% of all new cancers, with a noticeable increase in detection largely attributed to the rise in imaging investigations (Ibrahim AS et al., 2014;GLOBOCAN, 2020). Despite this increase, clinical guidelines still lack aconsensus on how to best manage thyroid incidentalomas detected by PET/CT, especially in resource-limited settings.

Previous studies have explored various semi-quantitative PET parameters, particularly SUVmax, as potential indicators of malignancy. Malignant thyroid incidentalomas tend to show significantly higher SUVmax values than benign ones, but considerable overlap exists, limiting its standalone diagnostic value (Shi H et al., 2018; Kim BH et al., 2013).

Furthermore, integrating ultrasound characteristics such as microcalcifications, hypoechogenicity, irregular margins, and taller-than-wide shape, has shown promise in enhancing diagnostic accuracy (Haugen BR etal., 2016; Russ G et al., 2017). However, data on how well these PET/CT and ultrasound features correlate with final histopathology remain limited in Egypt and other low-resource settings.

In a large meta-analysis, the pooled risk of malignancy in FDG-avid thyroid incidentalomas was estimated at 34.6% (Bertagna F et al., 2012), but single-center studies report wide variability, which may be due to differences in patient selection, imaging thresholds, and follow-up protocols. Given the growing detection of FDG-avid thyroid nodules and the lack of clear, standardized management protocols in Egypt, there is a critical need for localized research to guide decision-making and reduce unnecessary surgeries or missed malignancies

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All Adult patients referred for 18F-FDG PET/CT and found to have thyroid incidentalomas,

排除标准

  • •o Known history of thyroid malignancy.
  • •Previous thyroid surgery .

结局指标

主要结局

Assess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT

时间窗: 3 years

Assess the clinical significance of FDG-avid thyroid incidentalomas on PET/CT and explore correlations between SUVmax, TIRAD system on ultrasound, and final histopathology for suspicious lesion.

次要结局

未报告次要终点

研究者

发起方
Fatma Abelzaher Mahmoud Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatma Abelzaher Mahmoud Ahmed

fatma abdelzaher

Assiut University

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